The Ole' Apothecary

I've spent some time pondering my own issue. As the time approaches for FDA to debate whether or not to create the behind-the-counter (BTC), third class of drugs in the U.S., questions arise.  Egad, the questions! The American Society of Healthsystem Pharmacists (ASHP) supports the measure, and in its member-developed policy statement, adds the following:

Pharmacists have the education, training, and expertise to help patients make appropriate therapeutic decisions associated with the use of such drug products . . .

But, I ask you, will community pharmacists also have the time, and the equipment, to make these decisions? Will they be provided with sufficient breaks from the presciption blizzard to investigate and counsel the BTC patient properly?  Will they have access---ideally, online access---to the patients' latest medical record, including medical problem lists and current laboratory values? What will the pharmacist's responsibility be for adding documentation to the medical record? Which medications are likely candidates for BTC status? As one pharmacist blogged correctly a couple of days ago, will this become nothing more than pseudoephedrine duty with teeth, i.e., an unmanageable duty? If there is a sizable contingent of BTC drugs on the market, who will determine the size of the inventory, the pharmacist-in-charge, or, as I fear, the corporate moguls bent on coffer-padding instead of care-giving? 

As promising an area as this might be to community pharmacy, the BTC class could turn into a rip-roaring path for ambulance chasers to tread on.  I wonder if pharmacist liability insurance premium hikes would parallel BTC sales.
In any case, the above stack of questions ought to be well pondered by pharmacy, medicine, FDA, and the corporates before Pandora's box of pills is put on the pharmacy shelf.

Go tell the FDA what you think! On November 14, they are holding a public hearing on whether or not to create a class of U.S. drugs that are sold without a prescription,but not without the professional intervention of a pharmacist.  Such a class  is to be called behind-the-counter, or BTC, drugs.  Which medications should be placed in such a class? What should the pharmacist be required to do in order to dispense these products effectively? Will documentation be required? How much should the pharmacist be compensated? Until November 28, You can tell the FDA exactly what you think. Use the following link:

http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1756&SUBTYP=CONTINUE&CID=&AGENCY=FDA

The creation of a third drug class would represent a watershed in American pharmacy history.  It would reaffirm the neighborhood pharmacy as a true healthcare center, and confer upon the pharmacist new value and new respect. We cannot afford to let this pass us by. 

Before you respond to the FDA's online call for comment, you might peruse the list of considerations offered by the American Society of Healthsystem Pharmacists at http://www.ashp.org/s_ashp/cat1c.asp?CID=4235&DID=7544.   Study the issues, and respond thoughtfully. 

This is a really big one for pharmacy!

In one statute or another---federal and among the several states---the following words appear in the many controlled substances acts, and constitute the blade of every pharmacist's legal sword of Damocles:

A prescription for a controlled substance to be valid shall be issued for a legitimate medical purpose by a practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances shall be upon the prescribing practitioner, but a corresponding responsibility shall rest with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section one and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided by sections . . .

I heard those words echo across the television screen tonight. Not literally, of course; the folks on Fox News weren't reading them (I don't think they would recognize them for anything important if I sent them a copy). But today's story of increased interest in the drugs purported to have been found in the late Anna Nicole Smith's system, including the cry of "going after the doctors who overprescribe . . .and the (sic) druggists . . ." give life to the story that every pharmacy in the U.S. knows, that too many abusable drugs are being prescribed and dispensed. The Fox story yelled at the doctors, but made only oblique reference to pharmacists, for, after all, what are we? Who sees us in the Anna Nicole world? The doctors are almost as sexy as Anna, but pharmacists can only connote Mr. Whipple.

The story, however, left out the addicted public, the people who claim a divine right of kings to their oxycodone, hydrocodone, Xanax, Restoril, Ambien, Lunesta, Soma, and Ultram (the next drug to be scheduled!) at the pharmacy counter, with the battle cry, "I gotta have it!" I salute pathologist Dr. Cyril Wecht, who condemned the fact that the American prescription drug abuse epidemic did not need Anna to make itself known. It cuts across all levels of U.S. society. Dr. Wecht demanded that many other doctors, not just the physicians to the stars, be scrutinized for overprescribing abuse drugs. Problem is, the prescription abuse epidemic goes on because the lines of the prescriptions being issued "in the usual course of professional treatment" get very, very, very blurred. The scripts start out as being for back pain, or migraine, or a clinical anxiety disorder. But, where do they go, year after year? If they appear to be demanded according to the days' supply, who is to stanch the tidal wave of pills? The boards of pharmacy may as well shut us all down as an imminent threat to the public health and safety. But, as Dr. Wecht observed,the Controlled Substances Acts don't account for quiet desperation, only public tragedy. Still, Anna raised the issue from the grave, and it will be discussed for, oh, until the next sex murder scandal or the next pseudo-Columbine tale.

Drug Topics, 2 October 2007:

Fines for [state] pharmacists who fail to consult patients will increase significantly, to as much as $5,000, as the state pharmacy board looks to crack down on this omission. Unlike many states, [State] requires its pharmacists to consult with every patient picking up a new prescription. "Pharmacists have important information that needs to be communicated," argued ********, executive officer of the [state] pharmacy board. "The most important thing pharmacists can do is to consult with patients. This is not intended to be punitive." In some cases, pharmacies may be held responsible when staffing is not adequate. According to *******, the board is also updating its notice to consumers, which offers five questions patients should ask pharmacists.

This must mean, "We upped our fine---up yours!"

"Not meant to be punitive?" Does this board officer practice community pharmacy?

For decades, pharmacists have been presented with situations like this, which simply state the hazard and suggest that the practitioner proceed at his or her own risk, sort of like driving in a moutain construction zone. In the state mentioned in the article, and many other states, pharmacists are walking into legal minefields.  Call it what you will, Executive Director, but this action tends to dissuade rational people from practicing pharmacy in your state. Of course,  pharmacist-patient interaction is vital. But one might interpret the current climate of prescription blizzards and oppressive management as being anything but conducive to effective (fine-free) counseling.  I've never worked in the state involved, and I am unlikely to do so, so I don't know if this legal shotgun to the head really has resulted in improved pharmacy staffing in that state.  But it would seem that it is long past the time for pharmacists and pharmacy organizations to storm their boards of pharmacy for some kind of regulatory relief.  That would be wise counsel.

Our lives are frittered away by detail . . .simplify, simplify.   --Henry David Thoreau, Walden

 

On Friday, I went to my favorite vending machine for yet another Diet Dr. Pepper. As I dropped my quarters into the slot, I noticed, at the last moment, that the edge of one of the coins was a solid silver color, something I hadn't seen in years. I looked at the date. It read 1964. I had almost paid a 90% silver coin toward the price of a can of pop.  How many years had it been since I found one of those coins in circulation? I dropped it on a nearby counter to hear it ring (cupronickel coins do not make that same sound), then put it in a safe place in my wallet.  The texture of the coin made memories flood back: I was a young'un when much U.S. coinage was silver (the dime, the quarter, and the half dollar, which used to circulate).  The memories were cognate with this weekend's 50th-anniversary TV marathon broadcast of the classic series Leave It To Beaver. 

When that series debuted in 1957, its style and content were mainstream American entertainment. We had so much affection for its characters because we were those characters. We were June, Ward, Wally, and Beaver Cleaver.  The simplicity of life, or what I call today the good social order of the United States, was ours, and was the norm.  Children, born in wedlock, resided with their natural parents, and there was mutual love and respect, as well as the expectation that the social order was as eternal as the sun. 

During my retail years, I saw my customer-patients trace the dissolution of that good social order. The institution of the family was assailed from all sides. More and more, the love of chaos seemed to supercede the love of parent and child. Sexual abandon, drug abuse, and unleashed violence turned the Cleaver homes into slums. The spiritual currency of the Nation, once ringing silver, had become cheap clad.  And here, I long for it, and risk having my fellow citizens call me maudlin or sentimental or old-fashioned. Just because we have been breathing it for eons, is oxygen old-fashioned? So, then, is family love?

As pharmacists, we see the health of the nation being left to benefit managers and social engineers. I want us to have the courage, once more, to leave it to Beaver.  

Well, some day, birth control pills will come off prescription. Then they'll be placed at the front counter where the other patent medicines are. "Take your change in birth control!" ----George Carlin

. . .and you'll never get out of your car." ---1961 radio ad for Adventure Car Hop, Saugus, Massachusetts

In 1994, not long after I left the practice of community pharmacy, I found myself driving through downtown Worcester, Massachusetts. There, I saw a new, major chain drug store outlet under construction. A phrase that was mounted over a canopy struck me between the eyes: DRIVE-THRU PHARMACY. At first, I thought of the old drive-through pharmacies used in some areas in the 1950s, then became reminded of drive-through liquor stores, and, of course, fast-food restaurants. I was also reminded of the pride (sic) expressed by one former employer, who described the record prescription volume in one of his stores as "the closest we have come to mass production." So, now the system of automotive commerce was being extended to the practice of pharmacy. I really began to feel out of place. It was palpable now: the practice of community pharmacy was going to be re-engineered out of existence. They'll change the law; anybody can hand out finished prescription drugs. you'll get your Lipitor with fries, or even beer, if you wish.

But, even if the style of pharmaceutical care was to be changed, I knew then that something dangerous, even fatal, was happening to the pharmacist-patient relationship. The industry moguls had all but built a conveyor belt between the pharmacist and the public. And, judging by the result, the public has jumped right on it. Primary in the drive-thru's success is the notion that the customer is freed from moving his or her sick children from the car on the way home from the doctor's office. The drive-thru, however, was meant to be a prescription drop-off and pick-up center. It was not necessarily designed as a place for productive pharmacist-patient communication. Is the next step drive-through surgery? Drive up and stick out your ailing anatomy? The public, the pharmacy boards, and the medical community do not see it that way. They don't mourn the loss of natural talk between healthcare professional and subject. How many of you pharmacists and technicians get called "pill pushers?"

Until today, I had never driven my car into a pharmacy's drive-through lane. But, today my friend needed to pick up her new medication at a local major chain drug outlet. Regarding fast-food pharmacy, She didn't flinch. As I parked to go inside, she blurted, "Why aren't you taking the drive-through?" I confessed to her that I had never even considered it and had never done it. At first, I pulled in to it, and sat there for five minutes behind a small line of cars. Nothing moved. I grew impatient at this ridiculous scene, and suggested we go inside for faster service. There, the situation was far worse, with more than 20 people lined up at the two checkout stations at the prescription pick-up window. Back out to the drive-through. It turned out that the line would move us through in about 15 minutes. When we reached the exterior pick-up window, I beheld a pathetic sight: a glazed-eyed technician talking on two telephones at the same time (now, I know that's normal for most of you, but I haven't done retail in 14 years). Several minutes passed, and she barely got to ask cogently, "May I help you?" I announced my friend's name, and out came the prescription bag through the pick-up drawer. This wasn't pain medication, but it was a new medication for my friend. However, she was in a lot of pain, and I couldn't raise the issue of pharmacist counseling (how long would it have taken to get the pharmacist to the window? I served as her pharmacist for the moment.)

The 20th century took away prescription compounding, took away the human pace of pharmacy care, and, apparently, has also decimated any chance that a patient might have his or her own pharmacist to trust. Say what you want to say about the legal mandates we have, about counseling, drug utilization review, and the duty to warn, but for practical purposes, pharmacy is dead. If you don't think so, tell me what your pharmacist's name is. Today, I drove away from a cemetery, not a pharmacy. I envisioned mourners tossing mortars and pestles into a grave.

In the United States, there is an interesting tale of two cities: two Texarkanas. One Texarkana is located in the state of Texas, the other Texarkana adjacent to it, in the state of Arkansas. Crossing a street means entering (or leaving) a state. State laws and state pride have kept these two cities a certain political distance from each other. But wisdom may soon be overcoming traditional politics for this interstate municipality. An Associated Press story yesterday suggested that the two cities are pondering the efficiency that would be involved in becoming, partially, one. The potential savings involved in combining city services across the state border is $4.1 million. Some locals, such as attorney Hayes McClerkin, want to overcome the "territorial disputes and pride" that have blocked the commingling of revenue allocation across town. Translating the blinds of habit into economies of scale could set a great example for the rest of us, especially regarding the use of technology in healthcare.

Take my shoulder, for instance. I was in so much pain that I went to the local minor emergency center and had an X-ray taken of it. The E.R. doctor just thought I might have a touch of arthritis, but I begged to differ, and saw my orthopedist the following week. During his examination, I informed him about the X-ray taken a week earlier. He told me he could access it from the hospital's information system, right there from his office. Ten minutes later, he emerged with a detailed diagnosis for me: a bone spur. Focused exercise would help. Had he had to rely on retrieving a hard film to look at the image, I might have had to wait a day or two for him to order it to be shipped over to his office before I could ever get his clinical impression. But,, no longer---today, there is less waiting, less suffering, more action, and potentially, lower costs in many areas of healthcare.

Although my hospital set up a brand-new information system two years ago, and established computerized physician order entry (CPOE) just six months ago, the emergency department, run by a separate entity, chose not to opt in entirely. So, for STAT orders, it continues to insist upon sending orders on paper. The same order is in the CPOE system, but we in the pharmacy cannot act on them until the paper arrives. Meantime, to whatever extent one wants to measure it, the patient suffers. Turf is making the patient suffer. Who are we in pharmacy? Are we the enemy?

So, an additional blinder for us to remove here is the handwritten prescription. If I had my way, the handwriting of prescriptions would cease to be legal in the United States by 2020.

I've heard the current complaints over a lack of standards and a lack of formatting for the transmission of electronic prescriptions, and, of course, I don't disagree that we have problems in this area. So what? Sew buttons! It is time to correct those problems, and institute national standards for both transmission and connectivity of pharmacy information. It is time to smash the old turf lines of cutesy prescription blanks, perceived physician convenience, and sentimentality. Texarkana's calling!

In New Zealand, Go into Business-One Pharmacy in Auckland, to pick up your hydrochlorothiazide. Then, days or weeks later, say you are visiting Christchurch, and forget to bring your diuretic with you on the trip. You head into Business-Two pharmacy in that distant city for a refill . All pharmacies in New Zealand are connected. The pharmacist can call up your prescription information on a national network. So, HIPAA is a problem with this here in the U.S.? Maybe. Perhaps we need to examine, or amend, HIPAA to make this kind of connectivity possible from the mountains to the praries to the oceans white with foam. This kind of liberated information flow would be vital for a comatose patient bearing but a pocket ID in the ambulance.

I am originally from Massachusetts, and I remember studying about the Mayflower Compact, the first set of social rules among the people that would give rise to the U.S. We Americans of the 21st century need a digital compact for healthcare information. We need to emphasize the "P" in HIPAA. Anybody remember what the heck that stands for? Portable! We already have the tools and the skills to do it. Now, all we need is the handshake, both from hardware and from our hearts.